|RxNews Recap for Tuesday 02-23-10. SLXP leaps on FDA panel nod. PharmArthene higher on BARDA contract. IMMU up after patent award.|
|By Mary Davila|
|Tuesday, 23 February 2010 20:25|
Below is a list of the companies that made news in the healthcare sector on Tuesday , February 23, 2010.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) soared after hours today after the company reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).
"We are very pleased with the advisory committee’s support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years," stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. "We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today’s independent recommendation from the outside experts comprising the advisory committee reinforces the Company’s confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition."
Shares were halted during the regular trading session, when trading resumed in the after hours market they jumped nearly 20%, up $4.78.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the issue of U.S. Patent No. 7,666,400 covering PEGylated therapeutic agents that are constructed using the company's and its majority-owned subsidiary, IBC Pharmaceuticals, Inc's., proprietary dock-and-lock (DNL) technology.
"This extends our existing family of DNL patents to allow production of PEGylated forms of virtually any therapeutic agent. Products currently under development include PEGylated interferon alpha, granulocyte colony-stimulating factor and erythropoietin with superior pharmacokinetic properties," commented Cynthia L. Sullivan, President and CEO.
Also issued today was U.S. Patent No. 7,666,415, covering bispecific antibody constructs incorporating the company's proprietary histamine-succinyl-glycine (HSG)-binding 679 antibody.
Shares were up 7.42% to close the day at $3.62.
PharmAthene, Inc. (NYSE Amex: PIP) jumped over 11% today after the company announced that the Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA) has modified its existing research and development contract with PharmAthene providing for up to a total of $78.4 million in additional funding, provided that certain milestones are achieved and that all contract options and extensions are exercised by the government, to support the continued advanced development of SparVax, a second generation recombinant protective antigen (rPA) anthrax vaccine targeted for future procurement in the U.S. Strategic National Stockpile (SNS).
"We are pleased to be awarded additional development funding for our SparVax anthrax vaccine program, which may offer a promising improved alternative to existing anthrax vaccine options," commented David P. Wright, President and Chief Executive Officer. "There is widespread acknowledgement among various government agencies that the United States must develop and stockpile a second generation anthrax vaccine employing modern vaccine technology that offers the potential for improved safety, convenience and enhanced cost effectiveness. New and improved anthrax vaccines, based on modern state-of-the-art recombinant vaccine technology, incorporate significant product development and technological advancements and ultimately may provide meaningful health and economic advantages."
Shares of the biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, were as high as $2.54 in early trading and settled the day at $2.13, up 22 cents.
In news from after the bell:
Astro-Med, Inc., (NASDAQ:ALOT) announced after the bell today that it has collected $1,495,000 in damages from a lawsuit it filed against a former employee and a competitor business. At issue was the non-competition agreement which the employee had signed as a condition of employment with Grass Technologies, an Astro-Med, Inc. subsidiary.
Cytokinetics, Incorporated (NASDAQ:CYTK) announced today that four abstracts regarding its Research & Development programs were presented as posters at the Biophysical Society 54th Annual Meeting, held February 20-24, 2010 at the Moscone Center in San Francisco, California. The posters summarized non-clinical findings arising from Cytokinetics' skeletal and smooth muscle contractility programs, and non-clinical research in oncology. In addition, an oral presentation relating to non-clinical research in oncology was presented.
Hansen Medical, Inc. (NASDAQ:HNSN), the global leader in flexible medical robotics and the developer of robotic technology for accurate 3D control of catheter movement, today reported its business highlights and financial results for the fourth quarter and full-year ended December 31, 2009. "While the current selling environment remains challenging, I believe conditions have improved over the last several months and our pipeline of potential customers is healthy," said Frederic Moll, M.D., president and chief executive officer of Hansen Medical. "To drive demand in 2010, our efforts will focus on improving utilization within our installed base and communicating the benefits of recent enhancements to our technology, including our next generation Sensei® X Robotic Catheter System along with our more advanced catheters. We are also very excited about the progress we are making to develop a new platform for use in the arterial vascular system. Looking ahead, we believe this new platform and its expected clinical capability in complex vascular procedures potentially represent significant future market opportunities for Hansen Medical," said Dr. Moll.
ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA), today reported financial results for the quarter and the year ended December 31, 2009. Fourth quarter 2009 net revenue of $34.3 million increased 22% from the fourth quarter of 2008. For the full year, ISTA reported 2009 net revenue of $110.6 million, a 33% increase over 2008's full-year results. In addition, ISTA reported operating income of $2.1 million and positive cash flow of $2.7 million for 2009, exceeding the Company's goal of being operating income breakeven for the year.
"The solid financial performance we delivered to our shareholders in 2009 reflects the strength of ISTA's Xibrom in the cataract surgical setting and the benefit Istalol brings to glaucoma patients," stated Vicente Anido Jr., Ph.D., President and Chief Executive Officer of ISTA. "Because of several competitive situations that allowed us to gain greater market share for Xibrom, Istalol and Vitrase, we were able to raise guidance during 2009.
Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced that it has entered into a committed equity financing facility under which it may sell up to $20 million of its registered common stock to Commerce Court Small Cap Value Fund, Ltd. over an approximately 18-month period. Poniard is not obligated to utilize any of the facility and remains free to enter into other financing transactions.
Earlier in the day:
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the fourth quarter and full year ended December 31, 2009. "The FDA approval of AMPYRA represents an important advance in the treatment of MS. It is also a significant step for Acorda toward our goal of becoming a leading innovator in neurology," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "We expect commercial supply of AMPYRA to be available beginning in March. As we launch AMPYRA, we also are focusing on advancing our preclinical pipeline to the clinic. We believe GGF2 may have important applications in both cardiac and neurological conditions, and will look to demonstrate proof of concept initially in heart failure. We expect to file an IND for this indication in early 2010."
AmStem Corporation (OTCBB: AMST) announces that it has received approval from the Financial Industry Regulatory Authority (FINRA) for the Company's name change to AmStem Corporation from Stem Cell Therapy International and for its ticker symbol change to AMST from SCII as quoted on the Over the Counter Bulletin Board effective today, February 23, 2010.
BSD Medical Corporation (NASDAQ: BSDM) today announced that a study titled "BSD2000 Deep Hyperthermia Combined with Chemotherapy of PT regimen in Patients with Non-small Cell Lung Cancer" has been published in the current issue of The Chinese Journal of Lung Cancer (February 2010;13(2):132–135) by Yang, Zhao, and Wang. The clinical study, conducted at a prestigious hospital in China, involved 60 patients with non-small cell lung cancer (NSCLC) who were randomized to receive either chemotherapy (cisplatin and paclitaxel) combined with hyperthermia (delivered using the BSD-2000 Hyperthermia System) or chemotherapy without hyperthermia.
Catalyst Health Solutions, Inc. (NASDAQ: CHSI) announces its financial results for the fourth quarter and year ended December 31, 2009. For 2009, the Company reported revenue of $2.9 billion and net income of $65.2 million, or $1.48 per diluted share compared to revenue of $2.5 billion and net income of $50.4 million, or $1.16 per diluted share in the prior year.
Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) announced today that it has signed a non-binding Letter of Intent with the National Institute on Drug Abuse (NIDA) to conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst's formulation of vigabatrin, for the treatment of cocaine addiction. It is anticipated that NIDA, under their agreement with Veteran's Administration Cooperative Studies Program, will provide substantial resources for the trial and that Catalyst will contribute approximately $2.5 million in resources as part of the estimated $10 million trial cost.
Cephalon, Inc. (Nasdaq:CEPH) announced today that it has exercised its option to acquire Ception Therapeutics, Inc., following receipt of positive data from a clinical study in adults with eosinophilic asthma. A Phase II clinical trial of Ception's lead compound, CINQUIL (reslizumab), in 106 patients demonstrated improved asthma control in adult patients with moderate to severe asthma and eosinophilic airway inflammation, as measured by the primary study endpoint, a change in Asthma-Control -Questionnaire or ACQ score (p=0.054). In addition, an analysis of the FEV1, a measure of lung function, showed a statistically significant improvement with CINQUIL compared to placebo (p= 0.002).
"This study showed a strong treatment signal and compelling internal consistency on the effect of CINQUIL on measurements of asthma and lung function," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "These data provide confidence that CINQUIL shows a meaningful treatment effect in this patient population. We look forward to advancing CINQUIL into Phase three clinical trials."
Based on these Phase II results, Cephalon exercised its option to acquire Ception on February 22, 2010. Following the exercise of its option, Cephalon's obligation to enter into a merger agreement relating to the acquisition is subject to Cephalon's rights under, and Ception's satisfaction of certain conditions set forth in, the option agreement. The merger agreement is subject to customary closing conditions, including expiration of applicable antitrust waiting periods. Upon the closing of the merger, Cephalon would purchase all of the outstanding capital stock of Ception for $250 million, subject to adjustment for any third party debt held by Ception. Ception shareholders could receive additional payments related to clinical and regulatory milestones.
China Sky One Medical, Inc. (Nasdaq:CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today provided an update on the status of its eight products which were included in the No. 17 official announcement from the Ministry of Health of 2009 ("the Warning List").
In 2009, eight products manufactured by China Sky One Medical's main operating subsidiary, Harbin Tian Di Ren Medical Science and Technology Company ("TDR") were included on the Warning List due to product descriptions that may have been misleading to consumers. From the descriptions on the packaging it was unclear that the eight products, sold under the "Kangxi" brand, which included Coryza spray, Tinea Pedis spray, Tinea Pedis powder, two Gynecopathy Cleaning spray (For Men and Normal), Yelaixiang deoderant spray, Chufeng Tongluo spray and Yin Ke cream, were all registered in the PRC as "Disinfectant Products" rather than "Drugs." In the PRC, "Disinfectant Products" are a special category of medicinal products which are used to treat external skin diseases, known as dermatosis, and are sold over the counter.
Shares shot up 9.49% on heavy volume to close at $16.03.
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company will be presenting at the RBC Capital Markets Healthcare Conference at 8:00 a.m. EST on March 2, 2010, in New York City.
Derma Sciences, Inc. (Nasdaq:DSCI), a specialty medical device/pharmaceutical company focused on advanced wound care, today announced that the underwriter of its recent public offering has exercised its over-allotment option, resulting in the issuance of an additional 145,800 shares and warrants to purchase 48,600 shares. Derma Sciences closed its previously announced follow-on equity offering, for a total of 1,117,800 common shares and warrants to purchase 372,600 shares. Each share, together with a warrant to purchase one-third of a share, was priced at $5.00. The exercise price of the warrants in the offering is $5.50. The Company realized net proceeds of $4.7 million from this offering.
Proceeds of the offering will be used towards paying Comvita New Zealand for the perpetual worldwide licensing rights to MEDIHONEY®, Derma Sciences' market-leading Advanced Wound Care product. The proceeds will also be used to retire term debt, pay off the outstanding debt balance of a recent wound care business acquisition, and to support our growth initiatives.
Forest Laboratories, Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA). Bystolic is currently approved in the US for the treatment of hypertension.
However, FDA added information to the Specific Populations section of the product label under "Heart Failure" stating that in a placebo-controlled trial of 2,128 patients (1,067 with Bystolic, 1,061 placebo) over 70 years of age with chronic heart failure, on which the CHF submission was based, no worsening of heart failure was reported with nebivolol compared to placebo. If heart failure worsens physicians should consider discontinuation of Bystolic.
Forest Laboratories will continue to work closely with the FDA to discuss next steps.
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today that it has filed its Form 10-K with the Securities and Exchange Commission.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV1) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the approval of non-qualified stock option (“Options”) and restricted stock unit (“RSUs”) grants to Inspire’s President and CEO, Adrian Adams, pursuant to NASDAQ Marketplace Rule 5635(c)(4).
Inverness Medical Innovations, Inc. (NYSE:IMA), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, today announced the launch of another tender offer to acquire up to approximately 1,295,836 additional shares in Standard Diagnostics, or SD, a leading innovator of rapid diagnostics in Korea.
Merge Healthcare Incorporated (NASDAQ: MRGE) today announced that it has received numerous calls from investors about its proposal to acquire AMICAS, Inc. (NASDAQ: AMCS) for $6.05 cash per share, and that, in response Merge is providing additional information to clarify certain questions raised by investors.
Diagnostic Hybrids, a Quidel Company (NASDAQ: QDEL) has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its D3® UltraTM 2009 H1N1 Influenza A Virus ID Kit, a monoclonal antibody fluorescent staining kit for the specific identification of 2009 H1N1 influenza A in direct patient specimens or incubated tissue cultures. The D3 Ultra 2009 H1N1 Influenza A Virus ID Kit is to be used for individuals with signs and symptoms of influenza and who previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device such as the D3 Ultra Respiratory Virus Screening and ID Kit. Emergency use authorization allows for the early availability of important diagnostic and therapeutic tools "to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved and available alternatives."
S3 Investment Company, Inc. (PINKSHEETS:SIVC) today announced a new client for its wholly owned Redwood Capital subsidiary.
Solta Medical, Inc. (Nasdaq:SLTM), a global leader in the medical aesthetics market, today announced it has entered into a definitive agreement to acquire privately-held Aesthera Corporation, which is based in Pleasanton, California. Under the terms of the definitive agreement, Solta will acquire Aesthera for $5.25 million in Solta common stock and cash, with potential additional base line milestones of $750,000 for a consideration of $6.0 million. Excluding acquisition and integration related charges, the transaction is expected to be accretive to Solta Medical's earnings within twelve months.
Talecris Biotherapeutics Holdings Corp. (“Talecris”) (Nasdaq: TLCR) today announced its financial results for the three and twelve months ended December 31, 2009 and filed its 2009 Form 10-K with the U.S. Securities and Exchange Commission (SEC).
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.